FDA Re-Approves Diclegis, Once-Banned Morning Sickness Pill
A pill that was at one time given to women who suffered from morning sickness has been re-approved by the Food and Drug Administration after 30 years off the market.
The drug — a combination of doxylamine and B6 vitamins — was initially taken off the market because of fears that it caused birth defects, but subsequent research has shown that there is no connection between the medication and any types of developmental issues in newborns or developing fetuses.
The drug was on the market for close to 30 years after being approved in 1956 and will be on the shelves at drug stores by June under the name Diclegis. More than half of all pregnant women suffer from morning sickness, which is nausea (typically in the AM hours) that occurs during the first trimester of their pregnancy.
Fears in the 80's were stoked because of the previous findings that Thalidomide, a chemical used to treat morning sickness, caused birth defects if taken during the first trimester. That drug was swiftly taken off the market because it prevented the development of fully formed limbs during fetal development and babies were born with underdeveloped arms and legs.
The drug combines B6 vitamins with the antihistamine doxylamine in a time release pill that should be taken daily before morning sickness, as a preventative.
Not long ago, another drug, called Zofran, was determined to be safe for use to treat morning sickness. Zofran is currently used in Europe for morning sickness and was found to be completely safe for pregnant women. Cancer patients in the US are allowed to use this drug, but it was not approved for pregnant women in the US but can still be prescribed easily.
For this new approval, the FDA studied the effects of Diclegis in 261 women who had morning sickness because of pregnancy. The women were between seven and 14 weeks of pregnancy. The only side effects seen were drowsiness, which is common with antihistamine medications.